Clinolipid

"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...

CLINICAL PHARMACOLOGY

Mechanism of Action

Fatty acids serve as an important substrate for energy
production. The most common mechanism of action for energy production derived
from fatty acidmetabolism is beta oxidation. Fatty acids are important for membrane
structure and function, precursors for bioactive molecules (such as
prostaglandins), and as regulators of gene expression.

Pharmacodynamics

Pharmacokinetics

Metabolism and excretion

The fatty acids, phospholipids, and glycerol found in
lipid emulsions are metabolized by cells to carbon dioxide and water. The
metabolism of these substances results in the generation of energy in the form
of adenosine triphosphate (ATP). Some fatty acids are stored in the body in fat
tissue, cell membranes, or as intracellulartriglycerides. There is constant
turn-over of these tissues, with the result that the lipid components are
eventually metabolized to carbon dioxide and water. Carbon dioxide is expired
through the lungs. Water is excreted through the kidneys or lost through
evaporation/expiration through the skin, lungs, and other tissue surfaces. Some
lipids (i.e., phospholipids, cholesterol, and bile acids) are excreted through the
biliary system.

Clinical Studies

Two clinical trials (Study 1 and Study 2) in adults
compared CLINOLIPID injection to a pure soybean oil based intravenous lipid
emulsion. Although Study 1 and Study 2 were not adequately designed to demonstrate
noninferiority of CLINOLIPID injection to the soybean oil comparator, they
support CLINOLIPID injection as a source of calories and essential fatty acids
in adults. The lipid dosage was variable in Studies 1 and 2 and adjusted to the
patient's nutritional requirements.

Study 2 was a randomized, open label multicenter study
that enrolled 22 patients aged 32-81 years who required long-term parenteral
nutrition. Twelve patients received CLINOLIPID injection for a mean of 202 days
(range 24-408 days) and 10 patients received the comparator lipid for a mean of
145 days (range 29394 days). The two groups had similar outcomes for weight,
weight loss, mid-arm circumference and triceps skinfold thickness.